Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease

Phase 1

• Conditions: Limbal Stem Cell Deficiency
• Interventions: Other: cultured autologous oral mucosal epithelial cell sheet

• Registration Number: NCT03015779
• Lead Sponsor: He Eye Hospital

Brief Summary

The aim of this trials investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease.

Detailed Description

A number of external factors can result in limbal stem cell deficiency(LSCD), causing pain, pathological corneal epithelium regeneration, inflammation reaction and seriously visual loss. For patients with unilaterally damaged eye, transplantation of limbal tissue from the healthy eye can be used in the past years in the risk of inducing limbal stem cell damaged in the healthy eye. While graft of human leukocyte antigen matched allogenic limbal stem cells require immune suppressive medications, it can cause side effects in the body. Over the past 10 years, the clinical trials of application of cultured autologous oral mucosal epithelial cell sheet to treat LSCD have been emerged as a promising strategy in many countries. However, little study has been reported in China. This study investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease in China.

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-08
• Last Update Submitted: 2017-01-08
• Study First Posted: 2017-01-10
• Last Update Posted: 2017-01-10
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Male or female aged>=18 years old
• Normal intraocular pressure
• Normal Eyelid
• No cataract and retinal disease
• No ulcers and tumor in the mouth

Exclusion Criteria

• Severe Systemic infection
• History of acute phase of ocular and oral inflammation
• History of hyper sensibility or allergy to antibiotics or serum
• Women who are or may be pregnant
• Patients with infectious diseases
• Patients with other complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	cultured autologous oral mucosal epithelial cell sheet	cultured autologous oral mucosal epithelial cell sheet

Primary Outcome Measures

Name	Time	Method
The area of reepithelialization of corneal epithelium	3 months	The preoperative status of the eye will be recorded on the basis of clinical drawings and pre-and post-operative photographs. These pictures will be sent to two corneal experts in order to evaluate the results.; Judgement criterion: the results will be tested with a slit lamp: Normal: no epithelial loss; Mild: the area of epithelial loss \<1/3; Moderate: the area of epithelial loss \>1/3 \<2/3; Severe: the area of epithelial loss\> 2/3

Secondary Outcome Measures

Name	Time	Method
Improvement of best correct visual acuity	one year
Decrease of corneal neovascularization	one year